Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000395538
Ethics application status
Approved
Date submitted
7/09/2006
Date registered
7/09/2006
Date last updated
5/04/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Benefits of the ImPACT program: a supervised exercise program for colorectal cancer survivors after chemotherapy.
Scientific title
The feasibility and efficacy of a supervised exercise program on the rehabilitation of colorectal cancer survivors immediately following completion of treatment - evaluation of the ImPACT program.
Universal Trial Number (UTN)
Trial acronym
ImPACT (I'm Physically Active after Cancer Treament)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal cancer (post-treatment) 1361 0
Condition category
Condition code
Cancer 1453 1453 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Physical Medicine / Rehabilitation 1454 1454 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
study: 60 minutes of supervised aerobic exercise at a gym, 3 times a week for a period of 12 weeks.
Intervention code [1] 1329 0
Rehabilitation
Comparator / control treatment
control: usual care (patients will receive usual care from their oncologist, which will generally involve limited monitoring. They will be wait-listed for the rehabilitation program to begin after follow-up testing at 18 weeks, if desired.)
Control group
Active

Outcomes
Primary outcome [1] 2005 0
Feasibility of Program
Timepoint [1] 2005 0
Continuous and 6, 12, 18 weeks
Primary outcome [2] 2006 0
Self-report fatigue measurement scale: FACIT-Fatigue 13 point scale
Timepoint [2] 2006 0
At baseline, 6, 12, 18 weeks
Secondary outcome [1] 3473 0
Quality of Life: EORTC QLQ-C30
Timepoint [1] 3473 0
Baseline, 6, 12, 18 weeks
Secondary outcome [2] 3474 0
Health Related Physical Fitness: Modified Bruce Protocol
Timepoint [2] 3474 0
Baseline, 6, 12, 18 weeks
Secondary outcome [3] 3475 0
Adverse effects: standard haematological values
Timepoint [3] 3475 0
Baseline, 6, 12, 18 weeks

Eligibility
Key inclusion criteria
Confirmed Colorectal cancerCompletion of treatment (curative) within 4 weeks of enrolment in studyNon-smokerAble to exercise for at least 20 minutes (may be in 5 minute bouts).
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Known contraindications to exerciseFurther required treatment.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Dynamic (adaptive) random allocation, minimisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1590 0
University
Name [1] 1590 0
The University of Queensland
Country [1] 1590 0
Australia
Funding source category [2] 1591 0
Other
Name [2] 1591 0
The Wesley Research Institute
Country [2] 1591 0
Australia
Primary sponsor type
University
Name
School of Human Movement Studies, The University of Queensland
Address
The University of Queensland
St Lucia, Queensland, Australia
4072
Country
Australia
Secondary sponsor category [1] 1397 0
Hospital
Name [1] 1397 0
The Wesley Hospital
Address [1] 1397 0
The Wesley Hospital
451 Coronation Drive
Auchenflower
Qld 4066
Country [1] 1397 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3014 0
The University of Queensland
Ethics committee address [1] 3014 0
School of Human Movement Studies
The Unviersity of Queensland
St Lucia, 4072
Ethics committee country [1] 3014 0
Australia
Date submitted for ethics approval [1] 3014 0
01/06/2006
Approval date [1] 3014 0
22/06/2006
Ethics approval number [1] 3014 0
HMS06/2206
Ethics committee name [2] 3015 0
The Wesley Hospital, Brisbane
Ethics committee address [2] 3015 0
The Wesley Hospital
451 Coronation Drive
Auchenflower
Qld 4066
Ethics committee country [2] 3015 0
Australia
Date submitted for ethics approval [2] 3015 0
24/07/2006
Approval date [2] 3015 0
25/08/2006
Ethics approval number [2] 3015 0
2006/32

Summary
Brief summary
The study aims to identify the benefits of an exercise program for colorectal cancer survivors and look at the benefits of commencing the program immediately following chemotherapy completion.

It is hypothesised that the program will be safe and acceptable to the target population and that the exercise program will improve participants' rehabilitation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27936 0
Address 27936 0
Country 27936 0
Phone 27936 0
Fax 27936 0
Email 27936 0
Contact person for public queries
Name 10518 0
Rosa Spence
Address 10518 0
Human Movement Studies
The University of Queensland
St Lucia, QLD
4072
Country 10518 0
Australia
Phone 10518 0
+617 3365 6463
Fax 10518 0
+617 3365 6877
Email 10518 0
[email protected]
Contact person for scientific queries
Name 1446 0
Rosa Spence
Address 1446 0
Human Movement Studies
The University of Queensland
St Lucia, QLD
4072
Country 1446 0
Australia
Phone 1446 0
+617 3365 6463
Fax 1446 0
+617 3365 6877
Email 1446 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.